How To: Managing Off-Label Product Use

Wrap Manufacturer’s, this one’s for you! This is the second in our ongoing series “How To: Compliance.” Recently, a series of questions from some of our manufacturer members brought up and excellent discussion about off-label product use and how does that impact manufacturer liability, as well as foreseeable misuse and liability. We consulted with BCIA legal counsel to determine the best course of action. Any identifying details in the following scenarios have been changed.

First, let’s define foreseeable misuse. Foreseeable Misuse is the use of a product, process, or service in a way not intended by the supplier, but which may result from readily predictable human behaviour.

A manufacturer cannot be willfully ignorant about what is happening with their product. The CPSC expects manufacturers to be fully conversant in the issues and concerns facing the industry in which they operate. In legalese, the CPSC expects manufacturers to “know what a reasonably prudent manufacturer would know” about its products and those of its competitors.

“As a small artisan weaver, I limited my fiber options available in order to manage testing costs. However, I do have a separate customer base that purchases shawls and scarves, so I have continued to offer more unusual fiber options in shawl and scarf form. Scarves and shawls have a different tag and I have been VERY clear that they are only to be used as intended. Only labeled and tested baby wraps are marketed for carrier use. However, I have seen more than one instance of a customer using their shawl as a sling, or even having a scarf converted to a ring sling. I have concerns about this and am not sure how I should best address it.”

While this question is specific, we can draw parallels to any situation where a manufactured product is marketed one way and used another way. Here are some things to consider and a few action items to help you protect your business.

Manufacturers are not expected to ‘police’ the market. That being said, if you are clearly aware of off-label use, actions on your part that appear to condone or encourage off-label use could weaken your liability case in the event of an incident or in a government investigation.

Be mindful of what you (as the manufacturer) post and permit in your own monitored spaces, ie. in resale groups, in social media spaces etc. Are you allowing the sale of off-label products? Are you sharing images of off-label use? You can’t control what your customers are doing, but you can manage the online spaces under your control. And, if you note troubling sales on other platforms, like eBay, then you may be able to remove listings due to violations of that website’s terms and conditions.

It would be a good idea to post a note outlining accepted use as a FAQ on your main website/product page as well as in your resale space. It should be reasonably easy to find on your site and accessible for those seeking information. This will also help some of your brand advocates, your awesome fans, to help put a stop to the misuse, by providing them with a resource–a clear link to a FAQ–for use on on discussion boards. Sample wording might look something like this (feel free to modify to suit your situation):

Note on Baby Carrier Use and Safety

“Our (handwoven wraps/product of choice) have been designed and tested specifically to be robust enough to pass mandatory product safety requirements in place by the (government/regulator of our country/market of sale). You can use them with full confidence knowing that they have been subjected to rigorous and repeated testing by third-party, independent labs to confirm their strength and suitability to carry a child. While you may be interested in using one of other popular patterns/products as a baby carrier, the remainder of our products are not designed, have not been tested, nor are they intended to be used as wraps or any other baby carrier. If you intend to use our (fabric/product) as a baby carrier, please purchase a wrap specifically constructed for that purpose.”

Scenario B:

“I’m a small artisan weaver and I’ve decided to move away from selling baby wraps and will just be selling unfinished fabric for consumers to do what they want with. What do I need to consider if I do this?”

This is a tricky situation and risk minimization is going to come down to how your product is used, marketed, and what you are aware of. We have some manufacturers who have legitimately converted to being fabric manufacturers, they sell to ring sling, soft carrier, and accessories makers as well as to others well outside of the carrier industry. They do not sell their pieces in ‘wrap length’ sections or connect their consumers with a seamstress who can just ‘hem that product up for you in no time.’ While there is certainly a degree of foreseeable misuse potential here, this manufacturer has likely made the transition to becoming a fabric wholesaler.

In contrast, we have also seen manufacturers who seem to exclusively manufacturer 4.5m lengths of ‘unfinished cloth’ with a ready recommendation to a seamstress and social media feeds filled with images of product in use showing wrapped babies.

The first manufacturer needs to be mindful of foreseeable misuse and would do well to take similar precautions as outlined in scenario A. The second manufacturer has fully stepped over that line into willfully and knowingly ignoring current legal regulations, which is quite a bit more serious–both for consumer safety and from a liability perspective. In actuality the two manufacturers might be making a very similar product; but the way that product is advertised, presented, and made available suggests very different uses to consumers. Indeed, the CPSC and other regulators will often ask about a product’s marketing as one of their first questions and it factors strongly into their consideration. In addition, legally, a manufacturer has an obligation to offer products for sale that are suited for their intended purpose. The law is wise enough to discern a knowing “wink and a nod.” You can rest assured that nothing on the internet is truly “private.” If you post it, you can assume that someone will “screenshot it” or that the internet “Wayback Machine” will cache and store it for posterity. More importantly, by engaging in such action, you may be creating a safety issue for a child, a liability issue for your company, and a political or regulatory issue for the industry as a whole. Let’s just say this is not the path you want to take.

At this point in time there is absolutely no justification for continuing to make an untested product in a regulated product category (all wrap and carrier styles are now regulated in the US market). Doing so only leaves your business open to legal repercussions and increased liability. As business owners, the onus is on all of us to be showing good faith efforts to contribute to consumer safety by going above and beyond with thoughtful product imaging, appropriate use notes, and responsible marketing that contributes to the health of the overall industry, and in turn better advocates for and promotes babywearing.

*If you like what we do and find this information useful, please consider joining the BCIA today! Industry membership allows our organization to continue our mission.*